Vulvar lichen sclerosus (VLS) is a chronic inflammatory skin condition that affects the vulvar area, often causing itching, burning, and pain, and may lead to scarring and narrowing of the vaginal opening. The condition significantly reduces the quality of life and may increase the risk of cancerous changes if left untreated.
This clinical study aims to evaluate and compare three commonly used treatment methods for women with biopsy-confirmed vulvar lichen sclerosus:
Topical corticosteroid therapy (clobetasol propionate 0.05%),
Topical calcineurin inhibitor therapy (pimecrolimus), and
Platelet-rich plasma (PRP) injections, which use the patient's own blood plasma rich in growth factors to support tissue healing.
A total of 45 participants aged 30 to 80 years will be enrolled and assigned to one of the three treatment groups. The effectiveness of therapy will be assessed using standardized questionnaires about symptoms and quality of life, as well as microscopic evaluation of tissue samples before and after treatment.
The study seeks to determine whether platelet-rich plasma (PRP) can serve as a safe and effective first-line treatment option for vulvar lichen sclerosus and to improve our understanding of the best therapeutic approaches for this chronic disease.
Age 30 to 80 years.
Clinical diagnosis of vulvar lichen sclerosus confirmed by histopathological examination.
Ability and willingness to provide written informed consent for participation in the study.
Ability to comply with study procedures, including questionnaire completion and follow-up visits at baseline, 3 months, and 6 months.
Lack of written informed consent to participate in the study.
Prior treatment for vulvar lichen sclerosus (any systemic or topical therapy targeted at VLS).
Current or past vulvar neoplasia, including vulvar intraepithelial neoplasia (VIN) or vulvar carcinoma.
Other organic or dermatologic causes of vulvar symptoms that could interfere with diagnosis or outcome evaluation.
Parallel
Platelet-Rich Plasma (PRP) Treatment
Biological/VaccineAutologous platelet-rich plasma (5 ml) prepared using the Arthrex ACP Max™ Platelet-Rich Plasma System is injected subcutaneously and submucosally into clinically affected vulvar areas and sites of itching or pain. PRP is administered once at baseline following standard aseptic technique.
Clobetasol Propionate 0.05% Cream (Dermovate)
DrugParticipants apply clobetasol propionate 0.05% cream topically twice daily for the first 3 weeks, followed by once daily for the next 3 weeks. This regimen represents standard high-potency corticosteroid therapy for vulvar lichen sclerosus.
Pimecrolimus Cream (Elidel)
DrugParticipants apply pimecrolimus cream topically twice daily for 3 weeks, followed by once daily for the next 3 weeks. This regimen represents topical calcineurin inhibitor therapy for vulvar lichen sclerosus.
Change in DLQI (Dermatology Life Quality Index) Score
The DLQI questionnaire assesses the impact of vulvar lichen sclerosus on patient quality of life. Scores range from 0 to 30, with higher scores indicating greater impairment. The study will measure the change in DLQI from baseline to 6 months across the three treatment groups.
Change in VDSS (Vulvar Disease Symptom Score)
The VDSS evaluates symptom severity (itching, burning, pain, dyspareunia) associated with vulvar lichen sclerosus. The study assesses changes in total VDSS score over time to compare treatment effectiveness.
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Milosz Pietrus
Lead sponsor
Jagiellonian University
Sponsor institution
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